At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Scientist/Senior Scientist, Device, Inhalation Product in Durham, NC, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

This role is in Product Development and supports AZ’s pressurized metered dose inhalers (MDIs) mid to late stage product development activities.  The ideal candidate will support the technical development of inhalation devices for respiratory drug delivery, from early phase activities up to commercialization, by leading the design controls activities and corresponding documentation in compliance with current drug-device combination product regulatory standards. In addition to outstanding documentation and inter-personal skills, a strong technical engineering background as well as regulatory knowledge in medical devices is crucial. This role involves a lot of documentation.Responsibilities:

• May be a matrix CMC Lead for a complex global product development program, encompassing multiple product options and marketing companies. Actively manages broader AZ interfaces (e.g., AZDP, SweOps, On-market team, IPD network, etc.).
• Lead technical development teams with focus on product development, characterization, root cause analysis and risk mitigation.
• Provide guidance and oversee the development and execution of complex technical deliverables for the development of MDI drug product using both internal and external resources.
• Author protocols and development reports as well as general development reports bringing together data from multiple studies and disciplines into coherent development history summaries. Author finished product or CCS/formulation components specifications.
• Lead the development of new device technology and advancement of the current container closure system.
• Organize and interpret large data sets and communicate data impact or value to senior R&D leadership.
• Play an integral role in the design of the combination drug products and medical devices. 
• Lead design control activities for inhalation drug-device combination product development to ensure compliance with 21 CFR 820.
• Author, compile and maintain Design History Files for drug-device combination products and medical devices including user requirement specifications, design input requirements, design and development plan, risk management plan, design verification, design validation and design transfer plans and reports, etc.
• Work with cross-functional teams to agree on document strategy, collect information, obtain feedback and reviews on authored documents, reconcile reviewers’ comments and prepare the documents for approval.
• Organize, prepare and host design review meetings in order to ensure controlled and documented completion of typical device development stages (Concept Generation, Concept Development, Detailed Design, Design Verification, Design Validation, New Product Introduction/Tech Transfer phase).
• Lead and supervise risk management activities along with design and development process, including use, design and process-related risk evaluations using FMEA methodology, hazard analyses, risk summary reports, etc.
• Support Human Factors Engineering activities and documentation (e.g., HFE Plan)
• Support Tech Transfers and related documentation (e.g., Design Transfer Plan / Protocols / Summary Report).
• Foster collaboration internally with Analytical Sciences, MDI Manufacturing, Quality Assurance, and Regulatory Affairs to effectively deliver on product development goals.
• Author sections of regulatory documents (e.g., DMFs, INDs, NDAs, MAAs, etc) based on the design / results of protocols designed through project teams.  Work within the timelines set forth within the regulatory and corporate timelines for US and ROW submissions. Participate/lead the interactions with Health Authorities for regulatory meetings.
• Effectively plan, summarize and communicate technical development of pharmaceutical products within and outside the AZ organization. Manage/coordinate multiple AZ operation sites with various functions on product development.
• Lead and oversee drug product or CCS related investigations to determine root cause to atypical results.  Work closely with QA, analytical and manufacturing staff as well as outside resources (e.g., vendors) to meet this goal.  Communicate observations / make recommendations to senior staff which may eliminate or reduce reoccurrence.
• Represent the department as a subject matter expert in MDI product development, including MDI sciences, CCS development and product characterization.
• Lead cross-functional submissions team for US and international marketing applications.
• Plan/manage the clinical supply chain activities to support clinical trials.
• Hold technical accountability for one or more contain closure system components, including vendor management.
• Maintain lab notebook following SOP requirements and keep clear and complete records. Ensure GMP compliance where necessary.

Qualifications:Education:

• PhD – 4+ years, OR
• MS – 8+ years, OR
• BS – 11+ years of relevant industry experience.
• Degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical or Biomedical Engineering, Chemistry, Material Sciences or a similar applicable discipline.

Required:

• Minimum of four (4) years of experience in pharmaceutical development of inhalation dosage forms.
• Excellent written and verbal communication skills.  Capable of influencing through effective communications/presentations to internal and external audiences.
• Strong computer skills with demonstrated experience in working with JMP and the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Strong working knowledge of analytical methods, MDI formulation and container-closure systems, and manufacturing processes. 
• Deep understanding of ICH guidelines, USP/EP requirements and FDA/EU guidance on inhalation dosage forms.
• Working experience authoring IND/IMPD/NDA/MAA regulatory filings.
• Strong working knowledge of statistical analysis tools, especially experimental design and interpretation and multivariate analysis of complex data sets.
• Working knowledge and experience with all aspects of medical device design controls under 21 CFR 820.30.
• Proven record of successful product development leadership and problem solving in the area of inhalation products and/or medical devices.
• Know how/when to apply organizational policy or procedures to a variety of situations.
• Working experience in a GMP environment.
• May require travel of 5 - 10% of working time.
• Must be able to operate a PC and sit and stand for extended periods of time.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

03-Feb-2020

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.